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Efficacy of NICE Classification in the Histological Evaluation of Colorectal Lesions

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ClinicalTrials.gov Identifier: NCT02033980
Recruitment Status : Unknown
Verified May 2016 by Zhizheng Ge, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
First Posted : January 13, 2014
Last Update Posted : May 10, 2016
Sponsor:
Collaborators:
Changhai Hospital
Peking University People's Hospital
Peking Union Medical College Hospital
Chinese PLA General Hospital
Information provided by (Responsible Party):
Zhizheng Ge, Shanghai Jiao Tong University School of Medicine

Brief Summary:
Recently, a new category classification (NICE classification) using non-magnified NBI has been proposed. We design this multicenter study to evaluate the reliability and validity of the NICE classification in diagnosing colorectal polyps by Chinese endoscopists during both image and real-time process.

Condition or disease Intervention/treatment Phase
Colorectal Polyps Device: NBI Not Applicable

Detailed Description:
Many reports have demonstrated the efficacy of narrow band imaging (NBI) with magnification in predicting the histology and invasion depth of colorectal polyps. In China, however, the magnifying endoscope is not used in some medical centers. Even in centers equipped with this technique, the magnifying colonoscope is not sufficiently used in daily practice. Recently, a simple category classification (NICE classification) using non-magnified NBI has been proposed, which classifies colorectal tumors into types 1-3 based on different characteristics of color, surface pattern, and microvessels. Type-1 is considered an index for hyperplastic lesions, type-2 is an index for adenoma or mucosal/SM scanty invasive carcinoma and type-3 is an index for deep SM invasive carcinoma. The new classification has soon arouse attention and been validated in some centers on the efficacy of differentiating adenomatous and hyperplastic polyps. However, most studies enrolled diminutive polyps less than 5mm and the efficacy of non-magnified NBI in differentiating type-2 and type-3 lesions has not been reported. To promote this simple classification, we design this multicenter study to evaluate the predictive validity and performance characteristics of the non-magnified NBI in diagnosing polyps during both image and real-time process.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Efficacy of NICE Classification in the Histological Evaluation of Colorectal Lesions ----- a Multicenter Study in China
Study Start Date : May 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : August 2017

Arm Intervention/treatment
colorectal lesions
All lesions will be observed with NBI and removed endoscopically or surgically for histological diagnosis.
Device: NBI
All detected colorectal lesions will be examined by high-definition NBI. For type 2 and type 3 lesions, subsequent magnifying NBI examination will be performed.
Other Names:
  • Evis Lucera system (CV-260, Olympus Inc, Japan)
  • high-definition colonoscopes (CF-H260AL, Olympus Inc, Japan)
  • magnifying colonoscopes (CF-H260AZL, Olympus Inc, Japan)




Primary Outcome Measures :
  1. Accuracy of NICE classification in histological prediction by gastroenterological fellows [ Time Frame: within two weeks after polypectomy ]
    Diagnostic accuracy of gastroenterological fellows using non-magnified NBI according to NICE classification in histological prediction of polyps, compared with histologic examination


Secondary Outcome Measures :
  1. Diagnostic accuracy of high-definition and magnifying NBI for type 2 and type 3 lesions. [ Time Frame: two weeks after endoscopical or surgical resection ]
    For lesions identified as type 2 or type 3, subsequent magnifying NBI examination will be performed by NBI experts. Before that, experts will make their own assessment according to all the images taken by gastroenterological fellows, blind to their diagnosis. Then experts will examine the lesions using magnifying endoscopy with NBI capability and make a new assessment.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with colorectal lesions during colonoscopy examination
  • Informed consent available

Exclusion Criteria:

  • Suspect of advanced colorectal cancer
  • History of colorectal surgery, familial adenomatous polyposis or inflammatory bowel disease
  • Poor bowel preparation
  • Patients under unsuitable conditions for examination or treatment, such as acute upper gastrointestinal bleeding, noncorrectable coagulopathy, severe systemic disease, etc

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033980


Contacts
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Contact: Zhizheng Ge, MD,Ph.D 86-21-58752345 zhizhengge@aliyun.com

Locations
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China
Ren Ji Hospital, School of Medicine, Shanghai Jiaotong University Recruiting
Shanghai, China, 200001
Principal Investigator: Zhizheng Ge, MD, Ph.D         
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Changhai Hospital
Peking University People's Hospital
Peking Union Medical College Hospital
Chinese PLA General Hospital
Investigators
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Principal Investigator: Zhizheng Ge, MD,Ph.D Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai ,China.

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Responsible Party: Zhizheng Ge, Ren Ji Hospital, School of medicine, Shanghai Jiao Tong University, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02033980     History of Changes
Other Study ID Numbers: rjxh[2013]125
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: May 10, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Zhizheng Ge, Shanghai Jiao Tong University School of Medicine:
narrow band imaging(NBI)
NICE classification
colorectal lesions
predicting histology